On Monday, Lyra Therapeutics, Inc. (NASDAQ:LYRA) experienced a shift in stock rating as BTIG moved its recommendation from Buy to Neutral. The downgrade came after the company announced unfavorable results from its Phase 3 ENLIGHTEN I study.
The clinical trial, which evaluated the effectiveness of LYRA's product LYR-210 in treating chronic rhinosinusitis (CRS), did not meet the primary endpoint. This endpoint was to show a statistically significant improvement over a sham control in a composite score of the three cardinal symptoms of CRS at 24 weeks.
The trial's outcome was unexpected as previous Phase 2 LANTERN and BEACON studies had presented promising data, suggesting the trial was low-risk. Still, the LYR-210 treatment did not perform significantly better than the sham procedure.
The mean improvement in the three cardinal symptoms for LYR-210 was a mere 2.13 compared to 2.06 for the sham, and the improvement in the intention-to-treat population was 2.35 versus 1.89 for the sham. Additionally, ethmoid sinus opacification, measured by CT scans, failed to reach statistical significance.
Despite the setback in primary endpoints, the safety profile of LYR-210 was deemed favorable, with no product-related adverse events reported. The ENLIGHTEN I study is still in progress, with data from the 52-week extension phase anticipated in the fourth quarter of 2024. Lyra Therapeutics also continues its ENLIGHTEN II study.
In response to the study's outcome, Lyra Therapeutics is planning immediate changes to its business operations, including a reduction in workforce to conserve financial resources. As of March 31, 2024, the company reported having $87.1 million in cash, which is expected to fund operations into the first quarter of 2025.
The decision by BTIG to downgrade Lyra Therapeutics reflects the lack of significant near-term catalysts following the study's failure. BTIG does not assign price targets for companies that it rates as Neutral.
InvestingPro Insights
The recent downgrade of Lyra Therapeutics (NASDAQ:LYRA) by BTIG after the disappointing results of the ENLIGHTEN I study has investors closely monitoring the company's financial health and stock performance.
According to InvestingPro data, Lyra Therapeutics holds a market cap of $25.42 million and has experienced substantial volatility with a 1-week price total return of -14.8% and a 1-month price total return of -19.72%, reflecting the market's reaction to the trial's outcome. Still, over the last six months, the stock has seen a large price uptick of 37.54%, and over the past year, it has generated a high return of 53.82%.
InvestingPro Tips indicate that Lyra Therapeutics holds more cash than debt on its balance sheet, which aligns with the company's reported $87.1 million in cash as of Q1 2024. This financial position may provide some stability as the company navigates through the current challenges.
Moreover, the RSI suggests the stock is in oversold territory, which could interest investors looking for potential entry points. Still, with analysts revising their earnings downwards and the expectation that the company will not be profitable this year, caution is advised.
For investors seeking a deeper analysis, there are 15 additional InvestingPro Tips available at https://www.investing.com/pro/LYRA. These can offer further insights into Lyra Therapeutics' financials and stock performance. To access these tips and detailed analytics, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.